Actively Recruiting
Abdominal Aortic Junction Tourniquet (AAJT-S) for Non-compressible Torso Haemorrhage: a Prospective Observational Pilot Study
Led by Medical University of Graz · Updated on 2025-04-17
10
Participants Needed
1
Research Sites
15 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the feasibility of using an Abdominal Aortic Balloon Occlusion device called AAJT-S for patients suffering from severe, uncontrollable bleeding in the torso due to trauma. This study is a prospective observational pilot conducted alongside the device's routine clinical use, focusing on emergency room and pre-hospital settings where patients experience life-threatening lower body trauma. The goal is to understand how well the device can be applied in these critical situations. The AAJT-S device application is not a study-specific intervention but part of clinical routine. The study observes its use during emergency care to control bleeding in patients suspected to benefit from trauma resuscitation with AAJT-S or an alternative called REBOA zone III. There are no separate treatment arms or randomization, as the study purely monitors the device's implementation in practice. Participants will be monitored for successful device placement within one hour and followed up for heart rate, blood pressure, base excess, complications over 90 days, and mortality within 30 days. Data collection involves clinical assessments during and after emergency care to evaluate safety and effectiveness indicators. The study begins in November 2024 and continues until January 2027, with participant involvement primarily during emergency treatment and subsequent follow-up.
CONDITIONS
Brief Title
Abdominal Aortic Junction Tourniquet (AAJT-S) for Non-compressible Torso Haemorrhage
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged, or believed to be aged, 18 years or above
- Confirmed or suspected life-threatening lower body trauma with signs like poor tissue perfusion, rapid heartbeat, low blood pressure, or suspected blood loss
- Thought to benefit from trauma resuscitation with AAJT-S or REBOA zone III
You will not qualify if you...
- Suspected additional bleeding source above the belly button
- Known or suspected pregnancy at presentation
- Known abdominal aortic aneurysm
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 hour
Participants who undergo routine care with the Abdominal Aortic Junction Tourniquet (AAJT-S) device are observed during its clinical use in emergency situations.
1 visit (in-person)
Duration - Up to 90 days
Participants are monitored for outcomes including 30-day mortality and complications up to 90 days after device implementation.
Follow-up visits during 30 and 90 days
Trial Site Locations
Total: 1 location
1
Medical University of Graz
Graz, Styria, Austria, 8010
Actively Recruiting
Research Team
G
Gabriel Honnef, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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